Wednesday, November 21, 2007

Drug Development for Dummies

DrugWonks is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.

Robert Goldberg
November 16, 2007
Jonathan Cohn, in an otherwise excellent and thoughtful piece in The New Republicv on how to shift health care systems to a value based reimbursement approach (from a single payer perspective) , resorts to the shibboleth that drug companies are not very innovative as if this is somehow their fault and by design. He relies on the totally useless work of Marcia Angell and Merrill Goozner, neither of whom know much about drug discovery and development and what they do write is selective and misleading.
First, if drug development and discovery were so easy it wouldn't be so expensive. Success rates have fallen not be design. Would any one want to invest $800 billion in a drug only to have it fail. But it happens all the the time. Incrementalism by the way is the norm of science and all things whereas the ability to use one medicine or insight to transform or extend life is rare indeed. Yet Cohn falls into the trap all amateurs fall into and believes that if drug or biotech companies tried a little harder they could nail it. That's arm chair quarterbacking at it's worst. If you think it's so easy to hit a Jaba Chamberlain splitter, why don't you try out for the Bosox and hit it not once every 1000 times but one out of three times. Hit .300 and you are in the Hall of Fame. My brother has worked for a drug company for 20 years and has 3 of the drugs he has worked on approved. That's a lot.
Now as to the heavy lifting. This notion that NIH discovers everything is just not true. The amount of collaboration is astounding and is what separates the US from other parts of the world. Angell and Goozner lie outright to avoid describing the partnerships that shape innovation in America and depict a Golden Age that never existed. Angell asserts that every breakthrough drug started without drug company involvement. She claims that Gleevec, the first cancer drug to target cancerous cells without side effects, was developed without any real input from Novartis, the company that makes the product. Angell says that Brian Druker, a cancer researcher at Oregon Health and Science University, said that Novartis showed little interest in the cancer compound until he discovered its tremendous properties. The real story--from the Journal of the National Cancer Institute--reflects the risky and collaborative nature of drug development, which requires massive capital and biopharmaceutical know-how to turn discoveries into effective treatments. An academic researcher and private company, working together, launched a revolution in the treatment of cancer. You wouldn't know it by reading Angell.
Goozner makes the same claim about drugs developed by Amgen. Everyone involved knows better.
Similarly both Goozner and Angell disdain the revolution in personalized medicine thereby ignoring genomic based science, something that Senator Obama has taken leadership on in the Senate along with Senator Richard Burr.
For instance, The Truth About the Drug Companies also claims there is no real evidence that any one drug is better than another or that most medicines really do much at all. And Angell goes as far as to say: "the idea that patients respond differently to me-too drugs is merely an untested and self-serving hypothesis." Rather, she says, "one or two drugs will do" for most medical conditions. And Goozner still can't figure out the difference between a surrogate end point like blood pressure and a genetic marker which both predicts and controls disease progression.
Cohn's article in the New Republic tries to argue that value based reimbursement can let people have the best of both worlds in a single payer system. I disagree. But he gets the point that health care is an investment and that innovation is valuable. I would recommend that he go beyond Goozner and Angell to understand the role the private sector plays in promoting innovation and just how difficult real invention is.

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